Z-0014-2014Class II

Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and...

Name: Z-0014-2014 Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and...
Creator: Synthes USA HQ, Inc.
Published: 2013-03-08
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-03-08 / Terminated / root cause: labeling and UDI

FDA source

Synthes USA HQ, Inc. began a recall of Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle on 2013-03-08. FDA classified it as Class II and gives the reason as "A post market safety review following several customer complaints indicated additional clarification was necessary in the Midfoot Fusion Bolt Technique Guide to reduce potential for bolt back-out or migration by...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0014-2014
Classification: Class II
Status: Terminated
Initiated: 2013-03-08
Posted: 2013-10-17
Terminated: 2015-08-12
Recalling firm: Synthes GmbH
Product: Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Product code: HWC Screw, Fixation, Bone
Reason for recall: A post market safety review following several customer complaints indicated additional clarification was necessary in the Midfoot Fusion Bolt Technique Guide to reduce potential for bolt back-out or migration by emphasizing the need for supplemental fixation.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: An "Urgent Notice: Medical Device Recall" letter dated March 8, 2013 was sent to customers asking them to check their inventory, remove all affected product technical guides from use, and return them to Synthes along with the Verification form. Customer questions were directed to (610) 719-5450.
Quantity in commerce: 62
Distribution: Nationwide Distribution, including the states of MI, PA, SC, IA, MA, CA, WI, IL, and KS.
Product codes and lots: Part Nos.: 04.111.210, 04.111.220, 04.111.230. with Lot Nos.; 2294209 through 7587547.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0014-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0014-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-23	2013-10-17

Product code HWC

K081071Class IISynthes 6.5Mm Midfoot Fusion BoltSynthes (Usa) / cleared 2008-05-01

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)